Previously used surgical medical materials need to be sterilized prior to subsequent use. These different types of instruments and mechanical pieces are placed within a sterilization bag that has a region that is permeable to gas but impermeable to germs and bacteria. After sealing the bag, the sterilization is realized with a method using high temperature steam, ethylene oxide gas (EOG), and similar.
After the sterilization of the instruments, but before their use in surgery, the instruments are stored within the bag. During the surgery or the treatment, the bag is opened and the instruments are used.
At present, the designs of existing bags in the market present some disadvantages. For example, access to the sterilized material inside the bag can be inefficient and slow because the bag lacks devices and fittings necessary for such access. Another disadvantage of the existing designs is that some materials, such as tweezers and bistouries, have a weight and design that can break the bags due to an insufficiently resistant bottom. In addition, another disadvantage is the fact that they lack visual indicators that allow visualization of whether the bag is perfectly sealed, that can distinguish the type of sterilization used, and that can distinguish whether the sterilization was carried out in a correct manner, so as to guarantee the security of the bag's seal as well as the sterilization process.
The patent application EP 1550466A relates to a sterilization bag, used to store and to sterilize medical instruments that have sharp edges. The lateral edges and bottom are made of a gas- and steam-permeable material and of a material that is adhered to an upper opening, but this is different from the bag of the present invention.
The Mexican patent No. 178951 teaches a bag for sterilization of material, which incorporates a device for fast and safe opening of the bags once the material is sterilized, but that is also different from the bag of the present invention.
The Mexican patent application 1998/00678 teaches a bag for sterilization and conservation of material, which is similar to the bag of the present invention. It is made of a piece of flexible material like paper, which has a rectangular configuration. It is closed at its lower end with a double or triple bottom, two lateral sides which have a folded or bellows shape. The upper part, which constitutes the mouth or entrance of the bag for introducing the material to be sterilized, has a saw-toothed pattern along its width. The bag relies on a thread that is hidden in the internal part of the side folds to open the bag with greater rapidity and facility, but this bag is different from the bag of the present invention. The bag of the present invention has a double bottom along its lower edge, but this double bottom has an inner thermo-weldable pigmented-adhesive to achieve its hermetically sealed closure. The pigmentation of the adhesive allows visualization of whether it is perfectly sealed or not, guaranteeing its total hermetic closure. In the upper front there is a notch (for easy opening with a finger) in the central part facilitating the opening of the bag. The front and back of the upper part also have a sawed edge to prevent the personnel who use the bags from cutting themselves. In addition, the part where the thread comes off has a straight edge rather than a sawed edge, which facilitates, in a surprising way, the obtaining of the segment of paper for subsequent opening of the sterilized bag, hence avoiding the difficulty of opening the bag. In addition, the bag uses an inner thermo-weldable pigmented-adhesive for closing the upper part, which pigmentation allows visualization of whether the bag is perfectly sealed or not, thus guaranteeing its hermetic closure and sealing. The bag is closed longitudinally with a double line of pigmented adhesive, which guarantees a double security seal. This pigmentation allows visualization of whether or not the bag is perfectly sealed. In addition it has two indicators of sterilization that change color depending on the sterilization process carried out on the bags. It contains a legend and instructions of use in a water-based ink. This water-based ink can be used to identify whether there is a leak of water or steam in the sterilization process if the ink has flowed. For these reasons, this invention solves problems and has advantages that are not solved with the bag of the patent application 1998/006678 and the bag of the present invention is new and inventive in light of the present document.
The Mexican patent application 1999/001855 protects a procedure of applying a chemical agent with germicidal characteristics to the medical grade paper for the manufacture of bags of paper, mixed bags, etc. This will prevent these packages from serving as a vector or transport of microorganisms present in the environment or by manipulation.
This procedure comprises the following steps: a) The impregnation on the surface of the medical grade paper, with paper weight between 30 up to 100 g/m2, with an alcoholic solution of triclosan from 0.2% to 3.8% or an aqueous solution of benzalconium chloride from 0.2% to 3.8%, which must remain after the sterilization process is carried out; b) The impregnation of step a) is performed by flexographic impression or by means of photogravure or by coating and c) drying at a temperature of from 30° C. to 190° C. for an aqueous solution of benzalconium chloride and from 30° C. to 70° C. for an alcoholic solution of triclosan.
The bag of the present invention has new characteristics of design and manufacture that contribute to solving the problems of presently used bags for sterilization of material, which is why it is new and inventive in the light of the previous documents.